Device product
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Z-2634-2014
Product summary
- Event
- Event 68585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 Each
- Official record key
device-enforcement:Z-2634-2014
Official wording
Reason: Products were held at improper storage temperature
Code information: Lot: B011403
Distribution pattern: Distributed in the states of LA, OK, and TX.
Derived failure modes
-
Unknown
Products were held at improper storage temperature